Safety And Efficacy Of Irinotecan Plus Capecitabine As First-Line Treatment In Asian Subjects With Hepatocellular Carcinoma

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Hepatocellular

Treatments: Drug: Irinotecan plus capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00635323

XRP4174/2501

A5961080

Details and patient eligibility

About

To evaluate the safety and efficacy of irinotecan and capecitabine in Asian subjects with inoperable hepatocellular carcinoma.

Enrollment: 73 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asian subjects with histologically or cytologically confirmed hepatocellular carcinoma
• Inoperable disease (unable to completely remove surgically, presence of extra-hepatic disease, main portal vein or hepatic vein involvement)
• Eastern Cooperative Oncology Group performance status of ?2

Exclusion criteria

• Decompensated cirrhosis or stage C (Index>10) according to the Child-Pugh Classification
• Current history of chronic diarrhoea
• Reproductive potential not using adequate contraceptive measures

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

A

Experimental group

Treatment:

Drug: Irinotecan plus capecitabine